Ignite Creation Date:
2024-05-06 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05342259
Status:
COMPLETED
Last Update Posted:
2023-01-04
First Post:
2022-03-08
Brief Title:
Low Dose Caudal VS Dorsal Penile Nerve Block for Postoperative Analgesia After Circumcision
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
Low Dose Caudal VS Dorsal Penile Nerve Block for Postoperative Analgesia After Circumcision
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
in order to eliminate fear and anxiety Regional techniques are more effective than systemic opioids non steroidal anti-inflammatory drugs and acetaminophen for postoperative analgesia in circumcision The most preferred techniques are dorsal penile nerve block and caudal block
Objective To investigate the effectiveness of post operative analgesia and complications among dorsal penile nerve block caudal block and the combination of both
Patients and Methods Our study was carried out to compare the effectiveness duration of post-operative analgesia and the complications among dorsal penile nerve block DPNB caudal nerve block CNB and the combination of both This study will carrey out on 81 male patients aged from 3-12 years old undergoing circumcision The patients were divided into 3 groups each is composed of 27 patients group 1 including DPNB patients group 2 including CNB patients and group 3 for combined block This study compared between the three groups regarding the intra-operative vital data HRBP post-operative VAS scores and the complications nausea vomiting urinary retention itching constipation CNS depression
Objective To investigate the effectiveness of post operative analgesia and complications among dorsal penile nerve block caudal block and the combination of both
Patients and Methods Our study was carried out to compare the effectiveness duration of post-operative analgesia and the complications among dorsal penile nerve block DPNB caudal nerve block CNB and the combination of both This study will carrey out on 81 male patients aged from 3-12 years old undergoing circumcision The patients were divided into 3 groups each is composed of 27 patients group 1 including DPNB patients group 2 including CNB patients and group 3 for combined block This study compared between the three groups regarding the intra-operative vital data HRBP post-operative VAS scores and the complications nausea vomiting urinary retention itching constipation CNS depression
Detailed Description:
Cases were subdivided into three groups Group 1 included dorsal penile block patients Group 2 included caudal block patients Group 3 included combined block patients
Circumcision was performed under general anesthesia and dorsal slit technique was used
Study procedure
General anesthesia was induced and maintained by inhalation of sevoflurane in oxygen mixed with air gas flow A 22-G intravenous iv cannula was placed after induction Spontaneous respiration was maintained via a selected laryngeal mask airway and the inhaled sevoflurane was modified and maintained as 08 to 10MAC
Block techniques
Technique of the caudal block The patient was placed in lateral decubitus position for blind caudal epidural block A line was drawn to connect the bilateral posterior superior iliac crests and used as one side of an equilateral triangle then the location of the sacral hiatus was approximated by palpating the sacral cornua as 2 bony prominences the sacral hiatus was identified as a dimple in between A needle was inserted at 45 degrees to the sacrum and redirected if the posterior surface of sacral bone was contacted
A subjective feeling of loss of resistance suggests piercing the SCL but was associated with a miss rate up to 26 even in experienced hands The whoosh test performed by auscultation at the thoracolumbar region with a stethoscope while injecting 2 mL of air had a sensitivity of 80 and a specificity of 60 in adults Palpating for subcutaneous bulging on rapid injection of 5 mL air or saline had a positive predictive value of 83 and a negative predictive value of 44 The inaccuracy of using blind technique for caudal epidural injection in adults even confirmed by various tests is clearly evident
Drugs and doses used 05 mlkg of 025 Bupivacaine diluted by saline solution 09
Technique of Dorsal penile nerve block
Under aseptic technique and under ultrasound guidance A hockey-stick probe was used covered by transparent sterile dressing The probe was placed vertically over the pubic symphysis and the base of the penile shaft With adjustment of the probe a sagittal view of the penile shaft was produced Scarpas fascia was seen as a hyperechoic line superficial to the penile shaft Under real-time guidance the needle was inserted and advanced until its tip laid deep to Scarpas fascia ie within the subpubic space where local anesthetic was deposited The local anesthetic solution injected was 05 bupivacaine in a recommended volume 2 ml up to 3 years and an additional 1 ml for each3 years up to maximum 6 ml Combined block
The caudal block was performed then the patient was placed in supine position and the DPNB was done
Circumcision was performed under general anesthesia and dorsal slit technique was used
Study procedure
General anesthesia was induced and maintained by inhalation of sevoflurane in oxygen mixed with air gas flow A 22-G intravenous iv cannula was placed after induction Spontaneous respiration was maintained via a selected laryngeal mask airway and the inhaled sevoflurane was modified and maintained as 08 to 10MAC
Block techniques
Technique of the caudal block The patient was placed in lateral decubitus position for blind caudal epidural block A line was drawn to connect the bilateral posterior superior iliac crests and used as one side of an equilateral triangle then the location of the sacral hiatus was approximated by palpating the sacral cornua as 2 bony prominences the sacral hiatus was identified as a dimple in between A needle was inserted at 45 degrees to the sacrum and redirected if the posterior surface of sacral bone was contacted
A subjective feeling of loss of resistance suggests piercing the SCL but was associated with a miss rate up to 26 even in experienced hands The whoosh test performed by auscultation at the thoracolumbar region with a stethoscope while injecting 2 mL of air had a sensitivity of 80 and a specificity of 60 in adults Palpating for subcutaneous bulging on rapid injection of 5 mL air or saline had a positive predictive value of 83 and a negative predictive value of 44 The inaccuracy of using blind technique for caudal epidural injection in adults even confirmed by various tests is clearly evident
Drugs and doses used 05 mlkg of 025 Bupivacaine diluted by saline solution 09
Technique of Dorsal penile nerve block
Under aseptic technique and under ultrasound guidance A hockey-stick probe was used covered by transparent sterile dressing The probe was placed vertically over the pubic symphysis and the base of the penile shaft With adjustment of the probe a sagittal view of the penile shaft was produced Scarpas fascia was seen as a hyperechoic line superficial to the penile shaft Under real-time guidance the needle was inserted and advanced until its tip laid deep to Scarpas fascia ie within the subpubic space where local anesthetic was deposited The local anesthetic solution injected was 05 bupivacaine in a recommended volume 2 ml up to 3 years and an additional 1 ml for each3 years up to maximum 6 ml Combined block
The caudal block was performed then the patient was placed in supine position and the DPNB was done
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None